12 Participants Needed

Surgical Tissue Flap for Glioblastoma

TW
JB
Overseen ByJohn Boockvar, MD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Northwell Health
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Surgical Tissue Flap for Glioblastoma?

Research shows that surgical resection, which involves removing as much of the tumor as possible, is a key part of treating glioblastoma and can improve survival. Techniques like using imaging and neuronavigation help make the surgery more precise and safer, which might relate to the effectiveness of using a surgical tissue flap.12345

Is the surgical tissue flap procedure for glioblastoma generally safe?

The safety of surgical procedures for glioblastoma, including the use of surgical tissue flaps, can be affected by risks such as surgical site infections and the need for platelet transfusions. Infections occurred in about 7.9% of patients, and platelet transfusions were needed in 12.38% of cases, often due to factors like prior antiplatelet therapy and low preoperative platelet counts.678910

How does the Surgical Tissue Flap treatment for glioblastoma differ from other treatments?

The Surgical Tissue Flap treatment for glioblastoma is unique because it involves using a piece of tissue to cover or repair areas affected by surgery, which may help in healing and protecting the brain after tumor removal. This approach is different from other treatments that focus solely on removing the tumor or using drugs to target cancer cells.211121314

What is the purpose of this trial?

This study assesses the safety of using tissue autograft of a pedicled temporoparietal fascial (TPF) or pericranial flap into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients.The objective of the study is to demonstrate that this surgical technique is safe in a small human cohort of patients with resected newly diagnosed GBM and may improve progression-free survival (PFS).

Research Team

John Andrew Boockvar, MD | Northwell Health

John Boockvar, MD

Principal Investigator

Northwell Health

Eligibility Criteria

This trial is for adults over 18 with newly diagnosed GBM who are expected to live at least 6 months and can have an MRI. They must be able to undergo a specific surgery, use birth control if of reproductive potential, sign consent, have a KPS of 70% or more, and meet certain lab criteria. Pregnant women, those already treated for GBM or with active infections or other significant health risks are excluded.

Inclusion Criteria

Females of reproductive potential must have a negative serum pregnancy test and be willing to use an acceptable method of birth control
It is possible to perform TPFF and/or pericranial flap procedure.
Able to understand and willing to sign an institutional review board (IRB)-approved written informed consent document (legally authorized representative permitted)
See 8 more

Exclusion Criteria

Subject, if female, is pregnant or is breast feeding
Subject has an active infection requiring treatment
You have started chemotherapy or radiation treatment for glioblastoma.
See 6 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgical Treatment

Standard surgical resection followed by implantation of a TPF or pericranial flap into the resection cavity

1 week
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the surgical treatment, including MRI assessments and monitoring for progression-free survival

6 months
Multiple visits (in-person) at 24 hours, 7 days, 30 days, 60 days, 90 days, 180 days

Long-term Follow-up

Participants are monitored for overall survival and long-term safety outcomes

2 years

Treatment Details

Interventions

  • Surgical Tissue Flap
Trial Overview The study tests the safety of using one's own tissue (TPF or pericranial flap) surgically placed into the brain after tumor removal in patients with GBM. The goal is to see if this method is safe and might help extend the time without disease progression.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Surgical tissue autograft: TPF flap/pericranial flapExperimental Treatment1 Intervention
Use of a pedicled autologous piece of tissue called the temporoparietal fascial (TPF) flap or pericranial flap into the resection cavity of newly diagnosed glioblastoma multiforme (GBM) patients

Find a Clinic Near You

Who Is Running the Clinical Trial?

Northwell Health

Lead Sponsor

Trials
481
Recruited
470,000+

Findings from Research

In a study of 177 glioblastoma patients, only 7.9% developed surgical site infections (SSIs) after craniotomy, indicating that while SSIs are a concern, they are relatively infrequent in this population.
The analysis found no significant risk factors for SSIs, and surprisingly, patients who received early postoperative radiation had a lower incidence of SSIs, suggesting that rapid chemoradiation may be beneficial for optimal oncological outcomes.
Surgical Site Infections in Glioblastoma Patients-A Retrospective Analysis.Scheer, M., Spindler, K., Strauss, C., et al.[2023]
The review of cranial tumor surgeries revealed that complication rates can range from 9% to 40%, with deep venous thromboembolism (DVT) being the most common adverse event, occurring in 3% to 26% of cases.
Implementing standardized safety protocols, such as DVT prophylaxis and intraoperative navigation techniques, could potentially reduce the incidence of adverse events and improve patient outcomes in neurosurgery.
Patterns in neurosurgical adverse events: intracranial neoplasm surgery.Wong, JM., Panchmatia, JR., Ziewacz, JE., et al.[2012]

References

[Surgical resection of gliomas in 2008]. [2016]
Perilesional resection technique of glioblastoma: intraoperative ultrasound and histological findings of the resection borders in a single center experience. [2023]
Second surgery for progressive glioblastoma: a multi-centre questionnaire and cohort-based review of clinical decision-making and patient outcomes in current practice. [2023]
Surgery for gliomas. [2013]
FLAIRectomy in Supramarginal Resection of Glioblastoma Correlates With Clinical Outcome and Survival Analysis: A Prospective, Single Institution, Case Series. [2021]
Surgical Site Infections in Glioblastoma Patients-A Retrospective Analysis. [2023]
Risk factors for platelet transfusion in glioblastoma surgery. [2018]
Risk of intracranial hemorrhage with direct oral anticoagulants vs low molecular weight heparin in glioblastoma: A retrospective cohort study. [2023]
Patterns in neurosurgical adverse events: intracranial neoplasm surgery. [2012]
10.United Statespubmed.ncbi.nlm.nih.gov
Between-hospital variation in rates of complications and decline of patient performance after glioblastoma surgery in the dutch Quality Registry Neuro Surgery. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Advances in Glioblastoma Operative Techniques. [2018]
How I do it: anatomical resection of a large diffusive recurrent high-grade glioma for preservation of the central core. [2021]
13.United Statespubmed.ncbi.nlm.nih.gov
1.5-T Field Intraoperative Magnetic Resonance Imaging Improves Extent of Resection and Survival in Glioblastoma Removal. [2019]
[Microsurgical strategies of glioma located in lateral fissure area]. [2009]
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